Unisom with Pain Relief

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Stop taking the medicine and call your doctor if you still have a fever after 3 days, or you still have pain after 10 days (or 5 days if treating a child). Also call your doctor if your symptoms get worse, or if you have any redness or swelling.

If you need surgery or medical tests, tell the doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Applies to acetaminophen / diphenhydramine: oral capsule, oral liquid, oral tablet

Nervous system

Nervous system side effects from diphenhydramine have been reported frequently. These have included depression with drowsiness and sedation in nearly all patients treated. Motor skills may be impaired. Dystonic reactions have been reported after single doses of diphenhydramine.[Ref]

The CNS depressant effect of diphenhydramine parallels its plasma concentrations. The plasma concentration threshold for sedation is 30 to 42 ng/mL, and to cause mental impairment is 58 to 74 ng/mL. Patients should be warned against driving while taking diphenhydramine.

Dystonic reactions have been accompanied by dizziness, mental confusion, rigidity, lip and tongue protrusion, trismus, torticollis, and swallowing difficulties and generally resolve spontaneously. Toxic encephalopathy has been reported in a child with chicken pox treated generously with topical diphenhydramine.

Delirium has been reported in elderly patients with mild dementia following a small oral dose of diphenhydramine.[Ref]

Cardiovascular

Cardiovascular side effects including two cases of hypotension have been reported following the administration of acetaminophen.

Cardiovascular side effects of diphenhydramine have included hypotension, tachycardia, and palpitations.[Ref]

Two cases of hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Hepatic

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients with the use of acetaminophen. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Gastrointestinal side effects have been rare with the use of acetaminophen, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with the use of acetaminophen. In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Gastrointestinal side effects of diphenhydramine have been usually mild and included nausea and dry mouth.[Ref]

Renal

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.[Ref]

Renal side effects have been rare with the use of acetaminophen and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Hypersensitivity

Hypersensitivity side effects, including anaphylaxis and fixed drug eruptions, have been reported rarely in association with acetaminophen use.

Hypersensitivity side effects to diphenhydramine have included rash, pruritus and eczema. Photosensitivity reactions have also been reported.[Ref]

Most commonly, hypersensitivity to diphenhydramine has manifested itself in patients receiving systemic drug after being sensitized to it by topical application. Sensitization with systemic administration has also been reported.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Hematologic side effects such as hemolytic anemia, thrombocytopenia, and agranulocytosis have been rarely caused by antihistamines such as diphenhydramine.[Ref]

Dermatologic

Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have also been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Genitourinary

Genitourinary side effects have included urinary retention and dysuria as a result of the anticholinergic effects of diphenhydramine.[Ref]

Respiratory

Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.[Ref]

Some side effects of Unisom PM Pain may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.